The approval allows SciSparc to carry out the trial at the Hannover Medical School in Germany.
It is based on the condition that some additional data for SCI-110’s release and stability will be delivered within a period of 90 days.
Apart from Hannover Medical School, the trial will also be carried out at two other sites, namely Yale Child Study Center at Yale School of Medicine in Connecticut, US, and Tel Aviv Sourasky Medical Center in Israel.
SciSparc already received the Institutional Review Board (IRB) clearances from all three clinical sites. It has also obtained approval from the Israeli Ministry of Health to conduct the trial at Sourasky.
The Phase IIb trial aims to examine the efficacy, safety and tolerability of daily oral dose of SCI-110 in TS patients aged between 18 and 65 years.
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During the trial, patients will be randomised in a 1:1 ratio to treat with either SCI-110 or a matching placebo.
The trial’s primary efficacy objective will be to analyse tic severity change using the Yale Global Tic Severity Scale as a continuous endpoint at week 12 and week 26 of the double-blind phase as against baseline.
Its primary safety objective will be the evaluation of absolute and relative frequencies of serious adverse events for all the patients and, separately, for the patient groups treated with SCI-110 and placebo.
SciSparc CEO Oz Adler said: “SCI-110 represents a promising candidate in our pipeline, leveraging cutting-edge research and breakthrough scientific advancements.
“This Phase IIb Clinical Trial will enable us to rigorously evaluate the safety and efficacy of SCI-110, and we believe will further solidify its potential as a game-changing therapy.”